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FDA ANDA · ANDA076631

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: SANDOZ

APPLICATION
ANDA076631
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2020-11-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 10MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL

Approval history

2020-11-03Labeling · Supplement 34 · standardAP
2020-11-03Labeling · Supplement 37 · standardAP
2018-08-16Labeling · Supplement 32 · standardAP
2016-03-24Labeling · Supplement 29 · standardAP
2015-06-30Labeling · Supplement 27 · standardAP
2014-09-23Labeling · Supplement 19 · standardAP
2014-09-23Labeling · Supplement 16AP
2011-08-02Labeling · Supplement 15AP
2011-07-28Labeling · Supplement 14AP
2010-03-17Labeling · Supplement 13AP
2009-12-28Labeling · Supplement 11AP
2009-08-31Labeling · Supplement 9AP
2007-09-25Labeling · Supplement 7AP
2004-02-11Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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